Risperidone Oral Solution recall: Impurity Out of Spec
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex…
Why was Risperidone Oral Solution recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: KD4855, Exp 06/14
- Product
- Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex…
- Recalling firm
- Apotex Inc.
- Quantity
- 11,422 bottles
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- May 7, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)